Published: 2021-06-12 17:58
Last Updated: 2021-07-25 08:45
The US Food and Drug Administration announced that it has notified Johnson & Johnson that millions of doses of the Covid-19 vaccine produced in a problem plant cannot be used due to the possibility of contamination.
The Food and Drug Administration said in a statement Friday that "several" batches of the vaccine manufactured at the "Emerging Biosolutions" facility in Baltimore are not suitable for use. It is known that each production batch means a few million doses.
Neither the agency nor the company revealed the exact number of doses, but the New York Times estimated the number at 60 million, citing people familiar with the matter.
FDA scientist Peter Marks said these actions followed a comprehensive review of records, including production history at the facility and testing performed to assess product quality.
The factory was directed to temporarily halt production in April, several weeks after it was confirmed that batches of materials used in the production of the Johnson & Johnson vaccine were contaminated with components from the “AstraZeneca” vaccine, which led to the destruction of 15 million doses of Johnson and Johnson.
The Food and Drug Administration is looking into whether to allow the plant to reopen.
Sixty million doses of AstraZeneca produced there for donation abroad are now being checked for quality before they are shipped.
All Johnson & Johnson vaccines distributed and used in the United States are made in the Netherlands, not Baltimore.
On the other hand, an informed source explained that the Food and Drug Administration gave the green light to two batches of the factory-produced Johnson & Johnson vaccine - that is, 10 million doses of the single-dose regimen.
Other amounts of Johnson & Johnson remain under review.
"Johnson & Johnson is committed to producing safe, high-quality vaccines to bring health and hope to people everywhere," said the company's executive vice president, Cathy Wingle.
Meanwhile, Canada announced Friday that it will not distribute 300,000 doses of the company's vaccine produced at the Baltimore plant due to "quality concerns."
Health authorities in Canada are planning to inspect the facility this summer.
"Until this examination is completed, Canada will not accept any product or ingredients made at this site," Health Canada said in a statement.